Dr. Lisa VanLuvanee is the Chief Operating Officer and Vice President of Research and Development at Facet Life Sciences (formerly Virtual Regulatory Solutions, Inc.), a company devoted to helping small organizations progress their products to and through FDA. Dr. VanLuvanee has over 20 years of experience in the life sciences industry. Her expertise includes portfolio and product development strategies, regulatory submission strategies, clinical endpoint selection, dossier preparation and submission, and post-approval life-cycle management. She has worked on a variety of drug, biological, medical device, and combination products for cardiovascular, CNS (neurology and psychiatry), dermatology, GI, inflammation, infectious disease, ophthalmology, pulmonary, oncology, pain, urology (reproductive), and women’s health indications in both the pre- and post-approval space. Dr. VanLuvanee has also been involved in the development and approval of diagnostic and therapeutic radiopharmaceuticals since 2003. She leads the Facet clinical, CMC, and nonclinical regulatory team of experts who provide US regulatory affairs strategic and tactical support for drug, biologic, cellular, protein, and gene therapy, vaccine, medical device, and combination products for a variety of indications. Facet is a recognized industry expert in the US regulatory development and registration of diagnostic and therapeutic imaging agents and presented at a co-sponsored (SNMMI and FDA) PET radiopharmaceuticals workshop on Inspections Management and Regulatory Considerations.